Application 761262

Type
BLA
Sponsor
ABBVIE INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761262Skyrizirisankizumab-rzaa351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;SUBCUTANEOUS150MGNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkyriziRISANKIZUMAB-RZAAAbbVie Inc.7148c8eb-b39e-e20a-6494-a6df823928582026-06-15Warnings, Adverse reactionsExact identifier
application number: BLA761262
ndc (product): 0074-5015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85491SUPPL 2026-03-24
85438SUPPL 2026-03-20
85344SUPPL 2026-03-12
85309SUPPL 2026-03-09
83297SUPPL 2025-09-05
83296SUPPL 2025-09-05
83282SUPPL 2025-09-04
82182SUPPL 2025-05-14
78858SUPPL 2024-06-20
78848SUPPL 2024-06-20
77730SUPPL 2024-03-06
77720SUPPL 2024-03-05
77187SUPPL 2024-01-04
77181SUPPL 2024-01-04
73803ORIG 2023-03-20
72744ORIG2022-11-28
72158SUPPL2022-09-27
72157SUPPL2022-09-27
72154SUPPL2022-09-26
71361ORIG2022-06-21
71357ORIG2022-06-21
71352ORIG2022-06-17